One of the benefits of the Prometra II® drug delivery system is the ability to use a screening test and determine if this therapy will be beneficial for you and help manage your specific type of pain. A screening test will also help your physician see what dosages of pain medication may work the best for you.
There are several methods that may be used for the screening test, but the goal will be to simulate how the drug delivery system might work if it were implanted. You will normally go to a hospital or surgery center for your test.
With this test, you will have specialized pain medicine injected into your back near the spinal cord, simulating how the drug delivery will work. Your physician will then monitor your pain sensations and note how well your pain levels respond to the medication and at what dosage.
With this test, your physician will insert a tiny, narrow tube called a catheter into your back and attach it to a small pump. This simulates the continuous flow of medication that the pump is able to deliver once implanted, and your physician will be able to monitor your pain levels and how you respond to the medication.
There are some risks involved with the screening test, including bleeding, infection, and possible drug side effects. You should also tell your physician if you have an active infection at the time of the test.
When discussing and planning the procedure with your doctor, be sure to confirm your insurance coverage of the procedure and any required hospital stay well in advance.
Tell your doctor about the medications you’re taking, about your allergies, and about any surgeries you have had, as well as any reactions to anesthesia in the past.
Arrange to have someone accompany you to the hospital on the day of the procedure, and to have someone drive you home afterward. You may also need to have a friend or family member help you at home for a day or two after the surgery.
Before your surgery, your doctor will determine the most suitable spot in your abdomen for the pump in an effort to not interfere with clothing or daily activities.
Your doctor and the hospital will give you important instructions to follow before the surgery. Follow these pre-surgery instructions carefully.
In most cases:
On the day of the procedure:
The Prometra II® System will be implanted during a surgical procedure that usually lasts one to three hours and will take place at a hospital or surgical center.
You will be comfortably sedated and monitored by an anesthesiologist during the surgery. The physician will make an incision in the skin of your abdomen to place the pump. Then, a second incision will be made in your back to allow the catheter to be placed near the spinal cord. Then, the other end of the catheter will be threaded under your skin and connected to the pump in your abdomen, making the entire system internal and fully implanted. There are no components on the outside of the body. Once the system has been tested and checked, the incisions are closed and the surgery is completed.
As with any surgery, there may be risks including infection and spinal fluid leak. A so-called “spinal headache” is also possible. After the system is implanted, problems with the device may occur and require additional surgery. Improper functioning of the device can result in drug overdose or underdose that may have serious or life-threatening adverse effects. Possible complications with the device can include the catheter or pump moving within the body or wearing through the skin. The catheter could leak, tear, kink or become disconnected. The pump could stop if the battery runs out or because some other element of the system has failed. Additionally, inflammatory masses have been reported at the tip of the catheter, which may lead to complications.
Once the Prometra II® drug delivery system has been implanted and is filled with medication, it will begin delivering pain medication to you.
Note that it may take time – up to a few weeks – before you see the potential benefits of drug delivery therapy. Your doctor may begin reducing or eliminating your other pain medications during this initial period and will give you instructions on how to care for the incisions after the surgery. It is also normal to feel some tenderness or discomfort around the pump and catheter right after the surgery; it is part of the usual healing process.
If you notice severe swelling, pain, or redness around the incisions, alert your doctor.
Your doctor may prescribe medication to ease the pain from the surgery. You may also be asked to wear an elastic binder around your abdomen for additional comfort as you heal.
In general, your doctor may recommend that you avoid strenuous activities such as lifting, bending and twisting until healing is complete.
Over time, any tenderness around the pump and catheter will subside, and you will become less aware of the system itself. Once healed, the surgical sites need no special care.
Important: If you need an MRI:
In the future, you may require an MRI or Magnetic Resonance Imaging procedure. It is important that you alert your physician that you have an implanted Prometra II pump.
You can undergo an MRI with your implanted Prometra II Pump, provided your doctor and MRI technician follow certain scanning conditions. Always alert your doctor and technician well in advance of your MRI. If an MRI is required, your pump MUST be emptied of all medication prior to the MRI. Please review information here that outlines the specific instructions for having an MRI with the Prometra II Pump.
After your procedure, you will be provided with a patient ID card and MRI bracelet, and these items should be kept with you at all times. Both the patient ID card and MRI bracelet provide important information about your Prometra II pump to health care professionals. Provide a copy of your patient ID card to your physician and MRI technician prior to receiving an MRI. In an emergency situation, your MRI bracelet will provide information about your implanted Prometra II pump and direct the medical professionals treating you on how to find detailed MRI safety information. Your MRI bracelet should be worn at all times and your patient ID card should be kept in your wallet or purse near your driver’s license or other forms of identification.
WARNING: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH.
Avoid powerful magnets, such as MRI without first seeing your pump management doctor. Strong magnetic fields, such as those created in Magnetic Resonance Imaging (MRI) devices may cause the valves of the pump to open, resulting in the immediate discharge of the contents of the pump and catheter into your body which could result in a fatal overdose.
If an MRI is required, your doctor MUST completely empty your pump of all medication prior to the MRI. Your doctor may arrange for another method of pain relief while there is no medication in your pump.
Pump performance has not been established for MRI scanners at fields other than 1.5 T (Tesla). You should not have an MRI in any scanner other than a 1.5 T scanner under the conditions listed on your implant card.
You should inform your doctor who manages your pump if you are going to have an MRI. Your doctor will recommend whether or not an MRI is appropriate for you and ensure that your pump has been properly emptied and programmed to zero (0) flow prior to the procedure.
Make sure to inform the MRI technician that you have an implanted Prometra II Programmable Pump prior to entering an MRI scanner. To make this easy for you, a medical bracelet and implant card have been provided to you. These both have the phone number (855-356-9665) to call before an MRI scan to obtain the safe scanning conditions.
Your implant card and medical bracelet should be with you at all times. You will be asked at the MRI facility to remove all jewelry and your medical bracelet prior to entering an MRI scanner. Remember your medical bracelet, like other jewelry, contains metal and could cause burns where it contacts your skin. Thus, these should be removed prior to scanning.
During an MRI, you may notice a warming sensation around the pump or feel a tingling sensation. If the warming or tingling sensation is uncomfortable to you, the MRI should be stopped and the settings adjusted to reduce or eliminate the sensation.
During an MRI, you may also notice a slight tugging sensation at the pump. An elastic wrap can be used to reduce the tugging sensation.
Additionally, the metal in the pump will cause the MRI image to be distorted in the area around the pump. The MRI should be adjusted to minimize the image distortion.
After the MRI, your doctor will confirm the status of your pump and may require close monitoring after refilling the pump with medication to ensure the pump is operating properly.
It is recommended that you register the MRI conditions under which your implant can be scanned safely with the MedicAlert Foundation (www.medicalert.org).
There are several methods that may be used for the screening test, but the goal will be to simulate how the drug delivery system might work if it were implanted. You will normally go to a hospital or surgery center for your test.
